ISO 11040-7:2024
International Standard
Current Edition
·
Approved on
03 June 2024
Prefilled syringes — Part 7: Packaging systems for sterilized subassembled syringes ready for filling
ISO 11040-7:2024 Files
English
25 Pages
Current Edition
61.76 BHD
ISO 11040-7:2024 Scope
This document specifies a packaging system that is used to deliver sterilized subassembled syringes ready for filling in tubs and nests.
Downstream processes (processes after filling such as in house/outside transport, reprocessing) can result in specific requirements on the packaging system used to deliver sterilized subassembled syringes ready for filling. However, these requirements are not within the scope of this document.
NOTE 1 Glass barrels and sterilized subassembled syringes ready for filling, plunger stoppers, and plastic barrels for injectables are specified in ISO 11040-4, ISO 11040-5 and ISO 11040-6.
NOTE 2 ISO 11607-2 addresses validation requirements of sealing and packaging processes for medical devices.
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